BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2181469 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05102
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS EXPERIENCING TELEMETRY ISSUES WITH THEIR DEVICE. POSSIBILITY OF A DEAD BATTERY WAS REVIEWED. THE PT EXPECTED A LONGER LIFE FROM BATTERY, BUT DID NOT HAVE ANY RECORD OF PREVIOUS PT SETTINGS THAT A LONGEVITY ESTIMATION COULD BE CALCULATED FROM. IT WAS RECOMMENDED TESTING OF LEAD DURING IPG REPLACEMENT TO VERIFY LEAD INTEGRITY WAS GOOD. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MDT PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR IMPLANTED:| LEAD: MODEL 4351, LOT# NHT014823N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT014821N| EXPLANTED: